January 12, 2023
Switzerland announced it will implement MDCG 2022-18, to deal with MDR certification gaps under MDR Article 97. Find out the requirements and how to comply.
January 4, 2023
Find out what regulatory news you may have missed from Swissmedic in 2022, and the upcoming 2023 deadlines for medical devices & IVDs in Switzerland.
December 1, 2022
Manufacturers of Class D IVDs must appoint a Swiss Authorized Representative by 31 December 2022. This is required even if the device is CE Marked to the IVDD.
November 28, 2022
Today Swiss Parliament voted to allow FDA approved devices onto the Switzerland market, in addition to European CE marked devices. Read here to find out more.
November 18, 2022
Swissmedic hosted a seminar on the new IVD Ordinance in Switzerland. Read about the current situation with Europe, the IVDR, registration requirements & more.
September 13, 2022
Swissmedic published an update regarding its registration database: the Swiss Database on Medical Devices (Swissdamed). Find out when it will be released and who has to comply.
July 1, 2022
The deadline to appoint a Swiss Authorized Representative for Class I devices and System/Procedure Packs is quickly approaching. Find out how Casus can help ...
May 26, 2022
There is extensive activity surrounding the IVDR’s date of implementation today. Here we will discuss what is new, and the impact in the EU, Switzerland, and the UK ...
May 9, 2022
It’s official. Swissmedic will adopt the IvDO, which heavily references the IVDR.
On 4 May 2022 Swissmedic updated its website to state that the “provisions of the EU IVDR were transferred to a new Swiss ...